BEUDAMED
    21 results · 26ms · Sources: EU EUDAMED, US FDA

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    MEDLOGICS ML 4000, MODEL 4000

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526827936·ACHIMED ACHILLES SUPP BLACK V

    Harvard Cement normal setting, Single powder, Shade 15

    FDA UDI
    Harvard Dental International GmbH·EHAR70025151·Zinc phosphate cement

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756157902·Electrosurgical Pencil and Holster

    Metal Custom Rx

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746104725·BRACKET MEDIUM TWIN MAX LEFT/MAND RIGHT CUSPID ...

    HANK'S BALANCED SALTS NO. 200-2515

    FDA 510(k)
    FDA Class 1 ·Hematology

    MEDTRONIC

    FDA Adverse Event
    Injury ·MEDTRONIC INC·Product code DTB·October 14, 2002

    NA

    FDA UDI
    aap Implantate AG·04042409048364·K-wire with trocar point, ø2.5, L 150

    PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523148882·Straight Implant Trial 25mm x 9mm x 15mm

    NA

    FDA UDI
    aap Implantate AG·04042409048371·K-wire with trocar point, ø2.5, L 150

    ASAHI REXEED-LX SERIES DIALYZER

    FDA Adverse Event
    Injury ·ASAHI KASEI MEDICAL CO., LTD.·Product code KDI·May 4, 2012

    Shoulder pack (I) (2), code 900-2515 (1) GOWN IMP. XTRA REINF. XL TOWEL WRAP LEVEL Ill (1) TOWEL ABSORBENT 15" X 20" (1) GOWN XXL SMS IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (2) STRIPS TAPE 24" X 4" (1) SUTURE BAG FLORAL (1) SHEET SPLIT W/ADHESIVE 1 08" X 77" STD SMS (1) DRAPE SHOULDER SPLIT W/ADHESIVE (1) TABLE COVER REINFORCED 50" X 90" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    CLAVICLE PIN ASSEMBLY 3.0MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code HRS·March 13, 2013

    ECHELON*FLEX60

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GDW·February 28, 2011

    ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL·Product code HQL·February 26, 2008

    SHOULDER PACK (I) (2) 6/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Enforcement
    Class II ·Terminated·Customed, Inc·September 9, 2015

    Shoulder pack (I) (2), code 900-2515 (1) GOWN IMP. XTRA REINF. XL TOWEL WRAP LEVEL Ill (1) TOWEL ABSORBENT 15" X 20" (1) GOWN XXL SMS IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (2) STRIPS TAPE 24" X 4" (1) SUTURE BAG FLORAL (1) SHEET SPLIT W/ADHESIVE 1 08" X 77" STD SMS (1) DRAPE SHOULDER SPLIT W/ADHESIVE (1) TABLE COVER REINFORCED 50" X 90" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OJH·May 20, 2014

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013